Cleared Traditional

K922681 - CUTINOVA FOAM

K922681 is the FDA 510(k) clearance for CUTINOVA FOAM by Jobst Institute, Inc.. It is a Class 1 General & Plastic Surgery device (product code KMF) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K922681 · Jobst Institute, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
88d
Days
Class 1
Risk

K922681 is an FDA 510(k) clearance for the CUTINOVA FOAM. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Jobst Institute, Inc. (Toledo, US). The FDA issued a Cleared decision on August 31, 1992 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jobst Institute, Inc. devices

Submission Details

510(k) Number K922681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date August 31, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 38
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K922681.
DUODERM HYDROACTIVE DRESSING
K925993 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
NASAL CAVITY WOUND DRESSING
K923957 · Smith & Nephew Richards, Inc. · May 1993
COMFEEL(R) WOUND DRESSING SD
K925376 · Coloplast A/S · Mar 1993
COMFEEL WOUND DRESSING ORD
K922461 · Coloplast A/S · Aug 1992
COMFEEL WOUND DRESSING SD
K922466 · Coloplast A/S · Aug 1992
COMFEEL CONTOUR DRESSING
K920925 · Coloplast A/S · May 1992